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Published online before print October 8, 2008, doi:10.1212/01.wnl.0000335762.42177.07)
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Received March 21, 2008
Accepted August 6, 2008

Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood

Yann Mikaeloff MD, PhD*, Guillaume Caridade MSc, Samy Suissa PhD, and Marc Tardieu MD, PhD

From Assistance Publique-Hôpitaux de Paris, Service de Neurologie Pédiatrique and Centre de Référence National des Maladies Inflammatoires du Cerveau de l'Enfant (Y.M., G.C., M.T.), INSERM U822 (Y.M., G.C.), and INSERM U802 (M.T.), Hôpital Bicêtre, Université Paris Sud 11, Le Kremlin Bicêtre, France; and Division of Clinical Epidemiology (S.S.), McGill University and Royal Victoria Hospital, Montreal, Canada.


* To whom correspondence should be addressed. E-mail: yann.mikaeloff{at}bct.aphp.fr.

Background: The risk of CNS inflammatory demyelination associated with hepatitis B (HB) vaccine is debated, with studies reporting conflicting findings.

Methods: We conducted a population-based case-control study where the cases were children with a first episode of acute CNS inflammatory demyelination in France (1994–2003). Each case was matched on age, sex, and geographic location to up to 12 controls, randomly selected from the general population. Information on vaccinations was confirmed by a copy of the vaccination certificate. The odds ratios (ORs) of CNS inflammatory demyelination associated with HB vaccination were estimated using conditional logistic regression.

Results: The rates of HB vaccination in the 3 years before the index date were 24.4% for the 349 cases and 27.3% for their 2,941 matched controls. HB vaccination within this period was not associated with an increase in the rate of CNS inflammatory demyelination (adjusted OR, 0.74; 0.54–1.02), neither >3 years nor as a function of the number of injections or brand type. When the analysis was restricted to subjects compliant with vaccination, HB vaccine exposure >3 years before index date was associated with an increased trend (1.50; 0.93–2.43), essentially from the Engerix B vaccine (1.74; 1.03–2.95). The OR was particularly elevated for this brand in patients with confirmed multiple sclerosis (2.77; 1.23–6.24).

Conclusions: Hepatitis B vaccination does not generally increase the risk of CNS inflammatory demyelination in childhood. However, the Engerix B vaccine appears to increase this risk, particularly for confirmed multiple sclerosis, in the longer term. Our results require confirmation in future studies.


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Correspondence:

Read all Correspondence

Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood
Michel Lievre, et al.
Neurology Online, 10 Mar 2009 [Full text]
Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood
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Editor's Note
Richard J. Kryscio, PhD
Neurology Online, 10 Mar 2009 [Full text]

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